Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
Patient could not tolerate the oral typhoid; The patient took three doses and sent back a partial pack; Case reference number US-BN-2024-002169 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-1589) on 08-Jul-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack (explicitly coded as 'Inappropriate schedule of vaccine administered'). On an unspecified date, the patient could not tolerate the oral typhoid. At the time of the initial report, it was unknown if the patient recovered from the event 'drug intolerance'. The reporter assessed the seriousness of the event 'drug intolerance' as non-serious, and causality for the event 'drug intolerance' was provided as possible. Additional information received from a health care professional on 10-Jul-2024: included confirmation how many doses of Vivotif patient took. Additional information received from a health care professional via Med Communication (reference number: USBAV24-1616) on 10-Jul-2024: included additional reference number (USBAV24-1616).; Reporter's Comments: A male patient of unknown age took the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.